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the National Level, but Actions Are Needed to Ensure Timely 
Adjudication of Nonformulary Drug Requests' which was released on 
August 31, 2010. 

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Report to Congressional Addressees: 

United States Government Accountability Office: 
GAO: 

August 2010: 

VA Drug Formulary: 

Drug Review Process Is Standardized at the National Level, but Actions 
Are Needed to Ensure Timely Adjudication of Nonformulary Drug Requests: 

GAO-10-776: 

GAO Highlights: 

Highlights of GAO-10-776, a report to congressional addressees. 

Why GAO Did This Study: 

In 2009, the Department of Veterans Affairs (VA) spent nearly $4 
billion on prescriptions for veterans. In general, VA provides drugs 
on its national formulary. However, all VA medical centers must have a 
nonformulary drug request process that is overseen by their regional 
Veterans Integrated Service Network (VISN). This report responds to a 
House Committee on Appropriations report directing GAO to review VAs 
formulary process and to an additional congressional request. 
Specifically, GAO reviewed (1) the process VA uses to review drugs for 
its national formulary, (2) the approaches VISNs and medical centers 
take to implementing the nonformulary drug request process, (3) the 
extent to which VA ensures the timely adjudication of nonformulary 
drug requests, and (4) the mechanisms VA has in place to obtain 
beneficiary input on the national formulary and make the drug review 
process transparent. GAO reviewed VA policy guidance and VAs pharmacy-
related information technology (IT) initiatives, analyzed 2008 and 
2009 drug review data and 2009 nonformulary drug request data, and 
interviewed VA officials from the national level, each VISN, and a 
judgmental sample of four medical centers. 

What GAO Found: 

VA uses a standardized process to review drugs for its national 
formulary that is coordinated at the national level by its Pharmacy 
Benefits Management Services (PBM). The Chief Consultant from VAs PBM 
told us that most drug reviews are initiated in response to FDAs 
approval of drugs for use on the market. To begin the process of 
deciding whether to include a drug on the national formulary, PBM 
develops evidence-based drug monographs that include information on 
safety, efficacy, and cost. PBM seeks comments on these monographs 
from VISN and medical center staff and, when appropriate, subject-
matter experts. Once a monograph is complete, PBM sends it to its 
Medical Advisory Panel and the VISN Pharmacist Executive Committee, 
which review the monograph and vote on whether to add the drug to the 
national formulary. According to information provided by PBM, reviews 
for a majority of the drugs VA considered for addition to the national 
formulary in 2008 and 2009 were completed within a year of FDA 
approval, but there were a number of factors, such as safety concerns, 
that caused some to take longer. 

VISNs and medical centers vary in how they implement the nonformulary 
drug request process, including how they adjudicate nonformulary drug 
requests, collect and report required data to VAs PBM, and address 
appeals of denied requests. GAO found that IT enhancements could help 
facilitate more consistent implementation of the process. Although VA 
is working on replacing its pharmacy IT system, officials could not 
tell GAO whether components that would support the nonformulary drug 
request process will be implemented. 

VA requires that nonformulary drug requests be adjudicated within 96 
hours, but it is unable to determine the total number of adjudications 
that exceed this standard due to limitations in the way data are 
collected, reported, and analyzed. While the total number of 
nonformulary drug request adjudications that exceed 96 hours is 
unknown, GAO found that data reported to VAs PBM on quarterly average 
adjudication times for medical centers are sufficient to demonstrate 
that not all requests are adjudicated within this time frame. 
Additionally, PBM does not have the framework in place to ensure that 
appeals of denied nonformulary drug requests are resolved in a timely 
fashion. 

VA obtains input from beneficiaries on the national formulary mainly 
through Veterans Service Organization meetings and complaints, though 
some VISNs have taken additional steps to seek this input. Officials 
from VAs PBM told GAO that they make the drug review process 
transparent to veterans through national formulary information 
available on PBMs Web site, and some VISN and medical center 
officials described undertaking other activities to educate 
beneficiaries. At the national level, VA officials are considering 
options for increasing beneficiary input on the national formulary and 
improving the transparency of the drug review process, and most VISN 
and medical center officials told us there could be benefit to doing 
so. 

What GAO Recommends: 

GAO recommends that VA establish additional mechanisms to ensure 
nonformulary drug requests are adjudicated in a timely fashion. VA 
concurred with this recommendation. 

View [hyperlink, http://www.gao.gov/products/GAO-10-776] or key 
components. For more information, contact John E. Dicken at (202) 512-
7114 or dickenj@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

VA's Process for Reviewing Drugs for Its National Formulary Is 
Standardized: 

VISNS and Medical Centers Vary in Approaches to Implementing the 
Nonformulary Drug Request Process; Technology Enhancements Could 
Further Standardize the Process: 

VA's Efforts to Ensure the Timely Adjudication of Nonformulary Drug 
Requests Have Limitations: 

VA Has Some Mechanisms to Obtain Beneficiary Input on the National 
Formulary and Make Its Drug Review Process Transparent and Is 
Considering Additional Steps: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Comments from the Department of Veterans Affairs: 

Appendix II: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: Status of VA's Review of New Drugs Approved by FDA in 2008 
and 2009, as of March 2010: 

Figures: 

Figure 1: Key VA Officials and Entities for National Formulary 
Management at the National, Regional, and Local Levels: 

Figure 2: VA's Drug Review Process: 

Abbreviations: 

CPRS: Computerized Patient Record System: 

DOD: Department of Defense: 

FDA: Food and Drug Administration: 

IT: information technology: 

MAP: Medical Advisory Panel: 

OI&T: Office of Information and Technology: 

PBM: Pharmacy Benefits Management Services: 

PRE: Pharmacy Reengineering: 

P&T: pharmacy and therapeutics: 

VA: Department of Veterans Affairs: 

VHA: Veterans Health Administration: 

VISN: Veterans Integrated Service Network: 

VistA: Veterans Health Information Systems and Technology Architecture: 

VPE: VISN Pharmacist Executive: 

VSO: Veterans Service Organization: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

August 31, 2010: 

Congressional Addressees: 

In 2009, the Department of Veterans Affairs (VA) spent nearly $4 
billion on the 249 million prescriptions it dispensed to veterans, 
representing about 9 percent of VA's total health care budget. In 
general, medications provided through the VA pharmacy benefit must be 
prescribed by a VA provider, filled through a VA pharmacy, and listed 
on the Veterans Affairs National Formulary.[Footnote 1] The national 
formulary is a list of drugs, grouped by class, that VA providers are 
expected to use when prescribing drugs for veterans.[Footnote 2] 
Providers can request access to medications not listed on the national 
formulary when it is clinically necessary to do so, and all VA medical 
centers are required to have a nonformulary drug request process. 
[Footnote 3] Most drugs, whether on the national formulary or 
nonformulary, are ordered electronically through the Veterans Health 
Information Systems and Technology Architecture (VistA)--VA's health 
information technology (IT) system.[Footnote 4] In 2009, 94 percent of 
drugs dispensed by VA were national formulary drugs. 

Until recently, drugs not listed on the national formulary might have 
been available through formularies established at each of VA's 21 
regional Veterans Integrated Service Networks (VISN); however, 
effective January 2009, VA eliminated the use of VISN formularies, 
making the national formulary the only drug formulary used by VA. 
[Footnote 5] VA's Pharmacy Benefits Management Services (PBM) is the 
office within the Veterans Health Administration (VHA) responsible for 
administering VA's pharmacy benefit on a nationwide basis. VA's PBM 
works in conjunction with the Medical Advisory Panel (MAP) and the 
VISN Pharmacist Executive (VPE) Committee to manage the national 
formulary, and also provides guidance for VISNs and medical centers 
which are responsible for implementing the nonformulary drug request 
process.[Footnote 6] 

Members of Congress and interested stakeholders had questions about 
whether VA's policies and practices for managing the national 
formulary and processing nonformulary drug requests provide veterans 
with timely access to needed medications. Additionally, they had 
questions about the extent to which beneficiaries can provide input on 
the national formulary and if VA's process for reviewing drugs for its 
national formulary is sufficiently transparent. We conducted this work 
in response to a House Committee on Appropriations report associated 
with H.R. 3082, the 2010 Military Construction, Veterans Affairs, and 
Related Agencies Appropriations Bill, which directed us to review and 
report on VA's formulary process, and in response to a similar request 
from the Chairman, Subcommittee on Health, House Committee on Veterans 
Affairs.[Footnote 7] In this report, we (1) describe the process VA 
uses to review drugs for its national formulary, (2) describe the 
approaches VISNs and medical centers take to implementing the 
nonformulary drug request process, (3) examine the extent to which VA 
ensures the timely adjudication of nonformulary drug requests, and (4) 
describe the mechanisms VA has in place to obtain beneficiary input on 
the national formulary and make its drug review process transparent to 
them. 

To describe the process VA uses to review drugs for its national 
formulary, we reviewed VA policy guidance, such as VA's formulary 
management handbook.[Footnote 8] We obtained and summarized 
information provided by VA's PBM on drug reviews VA conducted in 2008 
and 2009 and identified (1) the number of reviews conducted, (2) the 
outcomes of these reviews, and (3) drug review completion times. We 
determined drug review completion times by calculating the amount of 
time elapsed from the date PBM reported a drug as approved by the Food 
and Drug Administration (FDA) to the date it reported VA completing 
its review of the drug.[Footnote 9] We also obtained information from 
PBM on the number of new drugs approved by FDA in 2008 and 2009 and 
whether VA had completed reviews of these drugs as of March 
2010.[Footnote 10] Additionally, we interviewed officials from VA at 
the national, regional, and local levels. Specifically, we interviewed 
national-level officials from PBM, including the Chief Consultant, and 
VPEs from the 21 regional VISNs.[Footnote 11] To interview officials 
at the local level, we identified a judgmental sample of four medical 
centers. We selected the four medical centers to achieve variation in 
the percentage of nonformulary drug prescriptions dispensed between 
2006 and 2009 and variation in the total number of prescriptions 
dispensed--both national formulary and nonformulary--during 2009. 
[Footnote 12] We also considered geographic location. From each 
medical center, we interviewed the chief of pharmacy and the physician 
pharmacy and therapeutics (P&T) committee chair. Finally, we observed 
a MAP meeting and interviewed some of the members. 

To describe the approaches VISNs and medical centers take to 
implementing the nonformulary drug request process, we reviewed VA's 
formulary management handbook and interviewed officials from VA's PBM, 
the 21 VPEs, and officials from our sample of four medical centers. 
Additionally, we obtained documentation from VA on its pharmacy-
related health IT initiatives and interviewed officials from PBM and 
VA's Office of Information and Technology (OI&T) who are responsible 
for designing and implementing these initiatives. We also reviewed our 
past and ongoing work on VA health IT initiatives.[Footnote 13] 

To examine the extent to which VA ensures the timely adjudication of 
nonformulary drug requests, we reviewed VA's formulary management 
handbook for policies to use as criteria, and determined that VA 
requires nonformulary drug requests to be adjudicated within 96 hours. 
We interviewed officials from VA's PBM, the 21 VPEs, and officials 
from our sample of four medical centers. We also obtained and analyzed 
quarterly nonformulary drug request data on the average time taken to 
adjudicate requests reported to PBM for calendar year 2009 at the VISN 
and medical center levels. We reviewed related documentation, 
interviewed knowledgeable VA officials, conducted tests for missing 
data, outliers, and obvious errors, and determined that data reported 
for 13 of the 21 VISNs and their medical centers were reliable for our 
purposes.[Footnote 14] 

To describe the mechanisms VA has in place to obtain beneficiary input 
on the national formulary and make its drug review process transparent 
to them, we reviewed VA's formulary management handbook as well as 
reviewed the Web site for VA's PBM for the type of information 
available to beneficiaries. In addition, we interviewed officials from 
PBM, the 21 VPEs, and officials from our sample of four medical 
centers as well as observed discussions at the MAP meeting we 
attended. We also interviewed officials from the Department of Defense 
(DOD) regarding its Uniform Formulary Beneficiary Advisory Panel and 
attended a meeting of this group.[Footnote 15] 

We conducted this performance audit from November 2009 through August 
2010 in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. 

Background: 

Formularies are used to help control pharmacy costs, enhance patient 
safety, and improve quality of care by, among other things, limiting 
drug choices to those a health care organization has determined are 
the most medically appropriate and cost-effective for a given patient 
population. As early as 1955, VA medical centers began using 
formularies, and at the time, each medical center maintained its own 
formulary at the local level. In September 1995, VA created a 
centralized group to manage its pharmacy benefit nationwide, now 
called PBM, and soon began the process of moving to a single, national 
formulary. As an interim step, VA established regional formularies 
operated by each VISN. On June 1, 1997, VA implemented the national 
formulary to help standardize veterans' access to care across the 
country, though the medical centers and VISNs continued to maintain 
their own local and regional formularies. In 2001, VA abolished 
medical center formularies and in 2009, VA eliminated VISN formularies. 

Discussion of the elimination of the regional VISN formularies began 
in 2005. In 2006, VA reviewed all drugs on VISN formularies that were 
not on the national formulary to determine if these drugs should be 
considered for inclusion on the national formulary. According to 
officials from VA's PBM, in cases where VA decided not to add a drug 
from a VISN formulary to the national formulary, VISN and medical 
center staff were given 6 months to appeal the decision. In the end, 
91 drugs from VISN formularies were added to the national formulary. 
Around the same time that this review was taking place, VISNs were 
asked to stop adding new drugs to their formularies, unless the drugs 
were also being added at the national level. 

While VISNs and medical centers no longer maintain their own 
formularies, VA's decentralized approach to developing VistA means 
that each medical center is still responsible for maintaining a local 
drug file that matches VA's national drug file.[Footnote 16] In 
addition to maintaining a local drug file, each medical center decides 
whether and how it will customize other VistA applications onsite. 
VistA contains over a hundred separate computer applications, 
including the Computerized Patient Record System (CPRS). VA providers 
can use CPRS to review and update patient medical records and to place 
electronic orders for medications, procedures, and tests. 

As part of its responsibilities for managing VA's pharmacy benefit at 
the national level, VA's PBM updates the national formulary listing, 
maintains databases that track drug use, and reviews data on 
nonformulary drug requests that it requires each VISN to report 
quarterly. PBM clinicians are responsible for maintaining a clinical 
portfolio on drugs for certain diseases, and are expected to 
continuously review information on new drugs that are relevant to 
their portfolio, as well as stay current on information on existing 
drugs. When appropriate, these clinicians will initiate a drug review. 
PBM works with MAP and the VPE Committee to conduct reviews of drugs 
for its national formulary, including the review of drugs approved by 
FDA for use on the market. 

In addition to working with VA's PBM on the national-level VPE 
Committee, each VPE works in conjunction with its VISN formulary 
committee at the regional level to provide oversight and guidance for 
national formulary management activities for the medical centers 
within the network.[Footnote 17] In turn, at the medical center level, 
each chief of pharmacy works with the local P&T committee to implement 
national formulary decisions and ensure compliance with these 
decisions. (See figure 1.) 

Figure 1: Key VA Officials and Entities for National Formulary 
Management at the National, Regional, and Local Levels: 

[Refer to PDF for image: entity chart] 

National VA headquarters: 

Top level: 
Veterans Health Administration (VHA) Under Secretary for Health. 

Second level, reporting to VHA Under Secretary for Health: 
Pharmacy Benefits Management Services (PBM) Chief Consultant. 

Third level, reporting to PBM Chief Consultant: 
PBM. 

Associated with PBM: 
Medical Advisory Panel (MAP)/VPE Committee. 

Regional Veterans Integrated Service Networks (VISNs): 

Top level, associated with National VA headquarters PBM: 
VISN. 

Second level, reporting to VISN: 
Chief Medical Officer; 
VISN Pharmacist Executive (VPE). 

Associated with VPE: 
VISN formulary committees; these committees are also associated with 
National VA headquarters, Medical Advisory Panel (MAP)/VPE Committee. 

Local VA medical centers: 

Top level: 
Medical Center Director. 

Second level, reporting to Medical Center Director: 
Chief of Staff. 

Third level, reporting to Chief of Staff: 
Chief of Medicine: 
- VA physicians; 
Chief of Pharmacy: 
- VA pharmacists. 

Associated with Chief of Pharmacy: 
Local pharmacy and therapeutics (P&T) committees; these committees are 
also associated with VISN formulary committees. 

Source: GAO analysis of VA documents and interviews with VA officials. 

[End of figure] 

Although nearly all drugs that VA providers prescribe are on the 
national formulary, in some cases, providers determine that it is 
clinically necessary to prescribe nonformulary drugs.[Footnote 18] VA 
monitors the prescription of nonformulary drugs to ensure appropriate 
use and accordingly, each VA medical center must have a nonformulary 
drug request process. While VISNs and medical centers are responsible 
for implementing the nonformulary drug request process, VA has 
outlined certain requirements within its formulary management 
handbook. The handbook states that, at the local level, each VA 
medical center is responsible for establishing a process to adjudicate 
nonformulary drug requests that ensures decisions are evidence-based 
in accordance with certain prescribing criteria.[Footnote 19] VA also 
requires that medical centers adjudicate nonformulary drug requests 
within 96 hours.[Footnote 20] Each medical center chief of staff is 
responsible for establishing a system to address any provider-
initiated appeals of denied nonformulary drug requests. 

At the regional level, VISNs are responsible for ensuring that medical 
centers have a nonformulary drug request process in place. Each VISN 
is also responsible for establishing a process to analyze nonformulary 
drug request data at the VISN and medical center levels to determine 
if the process is implemented appropriately and effectively in medical 
centers, and report these data to VA's PBM on a quarterly basis. 
Reported information must include the numbers of nonformulary drug 
requests received, approved, and denied as well as the average time 
taken to adjudicate completed requests. 

In addition to requirements for the nonformulary drug request process, 
the handbook requires that VISNs ensure that local forums exist where 
formulary issues can be discussed with veterans service organizations 
(VSOs) on an ongoing basis.[Footnote 21] While VSO meetings may also 
be held at the regional and national level, there is no requirement 
that these meetings organize specifically for the purposes of 
discussing formulary issues. 

We previously reported on the national formulary in December 1999 and 
in January 2001.[Footnote 22] We found that veterans had access to 
needed medications, but VA needed to improve its oversight activities. 
In our 2001 report, we recommended that VA take steps to better ensure 
that VISNs and medical centers comply with the national formulary and 
nonformulary drug request policies and procedures. VA responded to 
these recommendations by, among other things, having its PBM check 
drug utilization data--which tracks drugs dispensed across VA--for 
outliers and requiring that nonformulary drug requests be adjudicated 
within 96 hours. 

VA's Process for Reviewing Drugs for Its National Formulary Is 
Standardized: 

VA uses a standardized process to review drugs for its national 
formulary that is coordinated at the national level by its PBM. PBM's 
Chief Consultant told us that most reviews are initiated in response 
to FDA's approval of drugs for use on the market. To begin reviewing a 
drug for inclusion on the national formulary, clinicians from PBM 
develop evidence-based drug monographs that include information on 
safety, efficacy, and cost, and seek comments on these monographs from 
VISN and medical center staff. Completed monographs are then reviewed 
by MAP and the VPE Committee, who vote on whether to add the drug to 
the national formulary. A majority of the drugs VA considered for 
addition to the national formulary in 2008 and 2009 were reviewed 
within one year of FDA approval, but there were various factors that 
caused some reviews to take longer. 

VA's PBM Initiates Most Drug Reviews in Response to FDA Approval of 
Drugs: 

VA's drug review process is coordinated at the national level by its 
PBM, whose Chief Consultant told us that most reviews are initiated 
following FDA's approval of a drug for use on the market to determine 
whether to add the drug to the national formulary.[Footnote 23] While 
there are different types of FDA approvals, PBM's Chief Consultant 
said that most drug reviews are triggered by FDA approval of a new 
drug.[Footnote 24] PBM also initiates drug reviews to consider whether 
to remove a drug from the national formulary, such as in response to 
the emergence of new safety issues. Additionally, PBM officials said 
that they may decide to conduct a drug class review to determine 
whether there is superiority of one or more drugs in a class, or if 
the drugs are equivalent in terms of safety and efficacy. Such reviews 
are undertaken when VA is considering negotiating a drug contract or 
to determine a drug's place in therapy relative to other drugs in its 
class.[Footnote 25] 

According to VA officials, medical center staff can submit requests to 
their local P&T committees to review a drug for addition to or removal 
from the national formulary.[Footnote 26] P&T committees review and 
forward approved requests to their regional VISN formulary committees. 
If VISN formulary committees review and approve requests, they forward 
them to VA's PBM for consideration at the national level.[Footnote 27] 
In 2009, VISNs submitted 13 requests for drug reviews, and while 2 of 
the requests were later withdrawn, PBM approved all of the requests 
for national review. 

VA Uses Evidence-Based Drug Reviews and Relies on Internal 
Stakeholders to Select Drugs for Its National Formulary: 

VA uses a standardized process to review drugs for inclusion on its 
national formulary, which begins with a clinician from its PBM 
researching relevant literature to develop an evidence-based drug 
monograph. Each drug monograph includes the clinician's research 
methodology, safety and efficacy tables, and data on cost.[Footnote 
28] Further, the clinician may consult with VA subject matter experts 
to assist with the development of monographs when necessary. Once a 
draft of a monograph is ready, the clinician forwards it to the VPEs 
and requests that the document be disseminated to VISN and medical 
center staff, including physicians and pharmacists, for comment. 
Generally, within a period of 2 to 4 weeks, comments about the 
monograph are returned to the PBM clinician. The clinician compiles 
and reviews these comments, and incorporates any changes deemed 
appropriate to the monograph.[Footnote 29] 

Once VA's PBM has completed a drug monograph, MAP and the VPE 
Committee review PBM's findings and vote whether to add the drug to 
the national formulary based on an assessment of the drug's safety, 
efficacy, and cost as well as its relevance to the veteran population. 
[Footnote 30] While most members of MAP and the VPE Committee are VA 
staff, a clinical representative from DOD participates in the MAP and 
VPE Committee meetings and votes on MAP decisions.[Footnote 31] A 
number of MAP and VPE Committee members we interviewed told us that 
they consider a drug's safety and efficacy before they consider cost 
when reviewing a monograph. Most members also said that the two groups 
typically agree on national formulary decisions, but that when 
disagreements occur, they usually stem from operational issues, such 
as establishing process guidelines for ordering a drug within VA. In 
the event of a disagreement, VA's policy is that final decisions rest 
with MAP. 

MAP and the VPE Committee may also recommend that restrictions or 
criteria for use be developed to better ensure a drug's appropriate 
use.[Footnote 32] Criteria for use are reviewed by MAP and the VPE 
Committee and then sent to VISN and medical center staff for comment. 
Once comments are received, members vote to approve the final 
document. Officials from VA's PBM told us that MAP and the VPE 
Committee are also authorized to classify a drug as "no buy" for 
purposes of prohibiting its use in cases where there are serious 
safety concerns in a population similar to the VA population. However, 
as of April 2010, there were no drugs on the national "no-buy" list. 
In addition, PBM has developed national guidance to improve the safety 
of "off-label" prescribing, which occurs when providers prescribe 
drugs for indications other than those FDA has approved. While PBM 
authorizes its providers to prescribe drugs "off-label," it recommends 
that providers use an evidence-based approach and follow protocols 
established by their local P&T committee.[Footnote 33] Figure 2 
illustrates VA's drug review process. 

Figure 2: VA's Drug Review Process: 

[Refer to PDF for image: process map] 

Review: 

Clinicians from VAs Pharmacy Benefits Management Services (PBM) 
research relevant literature to develop an evidence-based drug 
monograph. VA subject matter experts offer comments, as appropriate. 

Pharmacist executives from each Veterans Integrated Service Network 
(VISN) receive the monograph and disseminate it to VISN and medical 
center staff, including physicians and pharmacists. VISN and medical 
center staff offer comments. 

Clinicians from PBM compile and review comments, and incorporate any 
changes deemed necessary. 

The Medical Advisory Panel (MAP) and the VISN Pharmacist Executive 
(VPE) Committee review the monograph and vote on the drug. 

Decision outcomes: 

1) Drug is included on the national formulary: 

* Restrictions or criteria for use are developed to better ensure a 
drugs appropriate use; or: 

* Restrictions or criteria for use are not necessary. 

2) Drug is made nonformulary: 

* Restrictions or criteria for use are developed to better ensure a 
drugs appropriate use; or: 

* Restrictions or criteria for use are not necessary. 

3) Drug is designated no buy to prohibit unsafe use. 

Source: GAO analysis of VA documents and interviews with VA officials. 

[End of figure] 

After MAP and the VPE Committee make national formulary decisions, 
VA's PBM updates the national drug file. VISN formulary committees 
communicate national formulary decisions to medical center P&T 
committees. P&T committees subsequently inform medical center staff of 
these decisions. Pharmacy IT staff at each medical center update the 
local drug file by matching the local drug file to the drug's code at 
the national level. PBM officials we interviewed stated that it is 
more difficult for some medical centers to update local drug files 
than others, generally due to IT staffing resources.[Footnote 34] 

In 2008 and 2009, VA considered 61 drugs for inclusion on the national 
formulary. Of those, MAP and the VPE Committee voted to add 11 drugs 
to the national formulary and to approve 50 drugs for nonformulary 
use. In addition, MAP and the VPE Committee voted to add either 
restrictions or criteria for use to 25 of these drugs to ensure they 
were used appropriately. According to officials from VA's PBM, MAP and 
the VPE Committee made the 50 drugs nonformulary for reasons including 
(1) they determined the drug under review offered no significant 
benefit over national formulary alternatives already available, (2) 
they determined that the drug would have limited use for the veteran 
population, or (3) they had concerns about ensuring the drug's safe 
and appropriate use, and therefore required prospective review. 

Drug Review Times Vary: 

The time it takes VA to review a drug varies and is primarily 
determined by whether there are factors that complicate the drug 
review process, such as safety concerns, and the drug's priority 
status. Of the 61 drugs that VA considered for addition to the 
national formulary during 2008 and 2009, information provided by VA's 
PBM indicates that 35 reviews were concluded within one year of the 
time FDA approved the drug and an additional 17 reviews were completed 
within 2 years of FDA approval. The remaining 9 reviews were completed 
more than 2 years after the FDA approval, with 4 of these reviews 
taking 3 to 5 years to complete. PBM officials reported a number of 
reasons why some of these reviews took longer than others. In some 
cases, safety concerns necessitated the development of criteria for 
use, which delayed the drug review process. For example, one drug, 
approved by FDA for the treatment of a rare blood disease, was 
determined to potentially increase a patient's risk of infection and 
took VA 18 months to review. Officials said that developing criteria 
for use increased review time because the criteria were complicated 
and required consultation with a hematologist. In other cases, reviews 
were delayed because there was a lack of reputable information, such 
as studies published in peer-reviewed journals. Additionally, drug 
reviews took longer when alternative drugs were already available on 
the national formulary and PBM decided to conduct a drug class review. 
PBM officials told us that drug class reviews can take twice as long 
as the review of an individual drug because they involve compiling 
information on multiple drugs. 

Officials from VA's PBM told us they experience a backlog of drugs to 
review because there are always more potential reviews than they can 
accommodate, and thus, they review high-priority drugs first.[Footnote 
35] Additionally, the officials said they have implemented strategies 
to alleviate the drug review workload, such as soliciting assistance 
from VISN and medical center staff to prepare and present drug 
monographs, and conducting abbreviated drug reviews when appropriate. 
[Footnote 36] Some VPEs we spoke with said that they can talk to PBM 
clinicians about moving a drug up on the priority list if necessary. 

In addition to the 61 drugs VA considered for addition to the national 
formulary in 2008 and 2009, we examined new drugs approved by FDA in 
2008 and 2009, and the progress VA made in reviewing them. (See table 
1.) According to information provided by VA's PBM, of the 52 new drugs 
FDA approved for use on the market in 2008 and 2009, VA either 
reviewed, or was in the process of reviewing, 38 of them as of March 
2010.[Footnote 37] Reviews of the remaining 14 drugs were pending, 
since VA categorized these drugs as a lower priority for reasons such 
as there being a viable alternative drug on the national formulary or 
the drug having limited use for the veteran population. 

Table 1: Status of VA's Review of New Drugs Approved by FDA in 2008 
and 2009, as of March 2010: 

Review complete: 
Approved in 2008: 9; 
Approved in 2009: 7; 
Total: 16. 

Review in progress: 
Approved in 2008: 8; 
Approved in 2009: 14; 
Total: 22. 

Review pending: 
Approved in 2008: 7; 
Approved in 2009: 7; 
Total: 14. 

Total: 
Approved in 2008: 24; 
Approved in 2009: 28; 
Total: 52. 

Source: GAO summary of information provided by VA's PBM. 

[End of table] 

Although drug review times vary, if providers determine that it is 
clinically necessary, veterans may be able to access a drug before a 
national review is complete. Officials from VA's PBM told us that, due 
to the length of time it takes for PBM to conduct a drug review, VISNs 
and medical centers may develop interim guidance for reviewing and 
approving nonformulary requests for a drug not yet reviewed at the 
national level. The officials said that the VISN or medical center 
creating interim guidance could develop drug monographs and criteria 
for use for the purpose of evaluating nonformulary drug requests. PBM 
officials also said that they neither encouraged nor discouraged this 
practice, and think it is common among VISNs and medical centers. 
Officials from one medical center we interviewed told us that they 
conduct reviews of drugs that have not yet been reviewed at the 
national level, and that if they approve a drug for nonformulary use, 
they typically develop local restrictions or criteria for use until 
national guidance is issued. Officials from another medical center 
stated that they would not decide whether to permit nonformulary use 
of drugs that have not been reviewed by MAP and the VPE Committee, but 
noted that if a veteran urgently needed one of these medications, they 
would forward the request to the VISN. 

VISNS and Medical Centers Vary in Approaches to Implementing the 
Nonformulary Drug Request Process; Technology Enhancements Could 
Further Standardize the Process: 

VISNs and medical centers vary in approaches to implementing the 
nonformulary drug request process, including how they adjudicate 
nonformulary drug requests, collect and report required data to VA's 
PBM, and address appeals of denied requests. We found that IT 
enhancements could help facilitate more consistent implementation of 
the process. Although VA intends to replace its pharmacy IT system, it 
is uncertain whether changes that would support the nonformulary drug 
request process will be implemented. 

Processes for Adjudicating Nonformulary Drug Requests, Collecting and 
Reporting Required Data, and Addressing Appeals Vary: 

The process for adjudicating nonformulary drug requests varies among 
medical centers, in part due to differences in local IT resources. 
Most medical centers use CPRS to electronically process nonformulary 
drug requests, though providers can also make requests outside of the 
system either through submitting paper-based requests or contacting 
adjudicating officials directly to verbally request nonformulary 
drugs.[Footnote 38] Further, the extent to which medical centers can 
automate CPRS depends on the availability of onsite IT expertise. Some 
medical centers, for example, are able to create drug-specific order 
templates in CPRS for nonformulary drugs. Officials from VA's PBM told 
us that these templates are interactive and prompt providers through 
criteria checks to ensure appropriate use. If criteria are met, the 
drug is automatically submitted for ordering. Although this method 
further automates the nonformulary drug request process and better 
ensures that information about the drug is easily accessible to 
providers, some VPEs told us that it can be challenging from an IT 
perspective and that not all medical centers have the IT resources 
needed to create order templates. One VPE told us that the VISN has 
created order templates so that medical centers with more limited IT 
resources can use them, and another VPE said that the VISN would like 
to do this. 

While some medical centers are able to create drug-specific order 
templates, most VPEs and medical center officials whom we interviewed 
told us that CPRS is used to create electronic nonformulary drug 
request forms, which providers submit to a pharmacist for 
adjudication.[Footnote 39] The format of these request forms can vary. 
For example, some may be used just for nonformulary drug requests, 
while others may be used more broadly to request both national 
formulary drugs that have restrictions and nonformulary drugs. 
Additionally, some nonformulary drug request forms may be populated 
with drug-specific information, while others require providers to fill-
in information for requested drugs. Officials from two of the four 
medical centers whom we interviewed cited challenges with using 
nonformulary drug request forms. For example, officials from one 
medical center told us that due to the way the nonformulary drug 
request form is designed, providers may not realize how to access 
information needed to justify their requests and subsequently have 
them denied. 

VISNs vary in the processes they use to collect required nonformulary 
drug request data and report these data at the VISN and medical center 
levels to VA's PBM on a quarterly basis. VPEs from 18 of the 21 VISNs 
told us they collect required data--which include the numbers of 
nonformulary drug requests received, approved, and denied, as well as 
the average time taken to adjudicate completed requests--from their 
medical centers and report them to PBM, while 3 VPEs said that they 
instruct medical centers to report nonformulary drug request data 
directly to PBM. VPEs from the 18 VISNs obtain nonformulary drug 
request data in a variety of ways, such as extracting data from shared 
databases, or requiring medical center staff to complete spreadsheets 
or input data into an internal VISN Web site. 

Medical centers have established different processes for addressing 
provider-initiated appeals of denied nonformulary drug requests, and 
one VISN has centralized the appeals process.[Footnote 40] The VPEs we 
interviewed stated that medical centers rely on different personnel to 
adjudicate appeals of denied nonformulary drug requests, such as the 
chief of staff, the chief of pharmacy, the P&T committee chair, or the 
entire P&T committee. Furthermore, the appeals process may involve 
several layers of review. For example, officials from one medical 
center explained that appeals are first routed to a pharmacy 
supervisor. If the pharmacy supervisor also denies the nonformulary 
drug request, it is forwarded to the chief of medicine for review. If 
the chief of medicine denies the request, the provider can make a 
final appeal to the chief of staff. Some VPEs also said that VISN 
chief medical officers and formulary committees may become involved in 
adjudicating appeals at the regional level. 

Technology Enhancements That Could Further Standardize the 
Nonformulary Drug Request Process Have Been Considered, but 
Implementation Is Not Planned: 

Based on interviews with VA officials, we found that IT improvements 
could facilitate more consistent implementation of the nonformulary 
drug request process among VISNs and medical centers, and some of 
these capabilities were included in the original scope of VA's 
Pharmacy Reengineering (PRE) project.[Footnote 41] Since 2001, VA has 
been working on PRE with the intention of improving pharmacy 
operations, customer service, and patient safety by replacing current 
pharmacy software with new technology.[Footnote 42] At the national 
level, VA's Office of Information and Technology is responsible for 
planning, executing, and providing oversight for PRE--which includes 
allocating resources to the project--while its PBM is responsible for 
developing and prioritizing PRE requirements.[Footnote 43] PBM 
officials told us that PRE was expected to make adjudicating 
nonformulary drug requests and to make collecting and reporting 
related data easier and more standard systemwide. For example, PBM's 
Chief Consultant said that with enhanced software, providers at all VA 
medical centers would be prompted to complete a series of criteria 
checks when requesting a nonformulary drug, and if met, the request 
would be automatically approved.[Footnote 44] PBM officials also 
stated that PRE would help improve data collection and reporting 
related to nonformulary drug requests if it is implemented as 
intended.[Footnote 45] VPEs from 15 of the 21 VISNs we spoke with 
stated that improvements could be made to VA's pharmacy IT system, and 
most cited various benefits that improvements could provide, such as 
better ensuring that prescribing criteria are adhered to and enhancing 
the ability to collect and report nonformulary drug request data. 

However, VA has recently restructured the PRE project and has not 
established plans for delivering all originally proposed capabilities. 
In July 2009, the department suspended IT projects--including PRE--
that had either fallen behind schedule or gone over budget.[Footnote 
46] Subsequently, the department instituted a new IT project 
management approach that, among other things, requires projects to 
plan and deliver releases of new IT functions in increments of up to 6 
months.[Footnote 47] In October 2009, VA restarted PRE with plans for 
an initial set of four increments and has since identified two 
additional increments, for a total of six increments. According to 
officials from VA's OI&T and PBM, the six increments reflect an effort 
to meet the department's highest priority pharmacy reengineering needs 
while delivering new IT functions more frequently.[Footnote 48] 
However, capabilities that directly support the nonformulary drug 
request process and related data collection and reporting are not 
included in these increments, and as of May 2010, future increments 
had not been planned. Furthermore, VA's development and implementation 
of future increments could be impacted by delays the project is 
experiencing with the first six increments. Specifically, while 
increment four was scheduled to be implemented by June 2010, in August 
2010 officials said that they intended to implement this increment by 
the end of the month. Officials also told us that increments five and 
six may not meet their estimated implementation date of December 
2010.[Footnote 49] As a result, the extent to which PRE will help 
standardize the nonformulary drug request process, as the project was 
originally envisioned, is uncertain. 

VA's Efforts to Ensure the Timely Adjudication of Nonformulary Drug 
Requests Have Limitations: 

Per VA policy, nonformulary drug requests must be adjudicated within 
96 hours; however, VA is unable to determine the total number of 
adjudications that exceed this standard due to limitations in the way 
data are collected, reported, and analyzed. While the total number of 
nonformulary drug request adjudications that exceed 96 hours is 
unknown, we found that data reported to VA's PBM on quarterly average 
adjudication times for medical centers are sufficient to demonstrate 
that not all requests are adjudicated within this time frame. 
Additionally, PBM has limited oversight of the timeliness of appeals 
of denied nonformulary drug requests. 

VA Is Unable to Determine the Total Number of Nonformulary Drug 
Request Adjudications That Exceed Its 96-Hour Standard, but Reported 
Data Are Sufficient to Demonstrate That Not All Are Completed within 
This Time Frame: 

VA policy requires that nonformulary drug requests be adjudicated 
within 96 hours, but it is unable to determine the total number of 
adjudications that exceed this standard due to limitations in the way 
data are collected, reported, and analyzed. As previously noted, VISNs 
are required to report nonformulary drug request average adjudication 
times at the VISN and medical center levels to VA's PBM on a quarterly 
basis. VA's decision to limit data collection and analysis of the 
timeliness of nonformulary drug request adjudications to average 
adjudication times has oversight implications compared to collecting 
and analyzing data on individual requests. First, without collecting 
and analyzing request-level data, the total number of adjudications 
that exceed 96 hours is unknown systemwide. Second, averages can be 
strongly influenced by the presence of a few extreme values, or 
outliers, and may not give an accurate view of the typical 
adjudication times at medical centers.[Footnote 50] 

Additionally, inconsistencies in the way nonformulary drug request 
data are collected and reported across VA means that data reported for 
some VISNs and their medical centers may not be entirely accurate or 
complete. VPEs for 8 of the 21 VISNs told us that medical centers in 
their regions may include requests for restricted national formulary 
drugs in the nonformulary drug request data that they report to VA's 
PBM.[Footnote 51] If quarterly average adjudication times were to 
exceed 96 hours at medical centers within these VISNs, it would not be 
possible to determine whether this was the result of requests for 
restricted national formulary drugs or requests for nonformulary 
drugs. PBM officials said that they were not aware of this practice 
and would remind VPEs that only requests for nonformulary drugs are to 
be reported. Also, VISNs and medical centers determine how they will 
collect and report data on nonformulary drug requests made through 
paper-based forms and direct verbal communications with adjudicators, 
and some medical centers may not include these types of requests in 
reported data. Specifically, officials whom we interviewed from one 
medical center told us that only requests for 26 nonformulary drugs 
are made through CPRS and reported to PBM, while other nonformulary 
drug requests are made through direct communications with adjudicators 
to manage workloads. The VPE for this medical center said that steps 
are being taken to ensure that it includes all nonformulary drug 
requests in the data it reports. Finally, six medical centers did not 
report nonformulary drug request data for every quarter in 2009. PBM 
officials told us they were not aware of this issue and would ensure 
that VPEs check that all medical centers report data. 

While VA is unable to determine the total number of nonformulary drug 
request adjudications that exceed 96 hours, we found that data 
reported to VA's PBM on quarterly average adjudication times for 
medical centers are sufficient to demonstrate that not all requests 
are adjudicated within this time frame.[Footnote 52] To conduct our 
review of the data reported to PBM, we limited our analysis to the 13 
VISNs and their medical centers where VPEs told us that requests for 
restricted national formulary drugs are not included in reported 
nonformulary drug request data. Therefore, even though reported data 
for these VISNs and medical centers may be incomplete due to, for 
example, missing paper-based and verbal requests, the data are 
sufficiently reliable to show that at least some nonformulary drug 
requests are not being adjudicated within VA's 96-hour standard. 
Specifically, we found that during 2009, 7 of these VISNs each had one 
or more medical centers that took longer than 96 hours--on average--to 
adjudicate nonformulary drug requests in a given quarter.[Footnote 53] 
Quarterly average adjudication times that exceeded 96 hours within the 
7 VISNs ranged from just over 97 hours at one medical center to 240 
hours at another medical center.[Footnote 54] 

Officials from VA's PBM told us that they analyze nonformulary drug 
request data aggregated at the VISN level to monitor the timeliness of 
adjudications; however, this approach may not alert them to 
adjudication problems occurring at medical centers. PBM officials 
stated that VISNs and medical centers are primarily responsible for 
ensuring compliance with nonformulary drug request policies; thus, 
while medical center-level nonformulary drug request data are 
collected and reported to PBM, it analyzes data aggregated at the VISN 
level to ensure timely adjudications and expects VISNs and medical 
centers to monitor medical center-level data. PBM officials told us 
that they would follow-up with VISNs if aggregated data showed an 
average adjudication time that was greater than 96 hours. However, 
while at least 7 VISNs had medical centers with reported quarterly 
average adjudication over 96 hours in 2009, none of the VISN-level 
averages exceeded VA's standard. 

VA's PBM Has Limited Oversight of the Timeliness of Appeals of Denied 
Nonformulary Drug Requests: 

At the national level, VA's PBM does not have the framework in place 
to ensure that appeals of denied nonformulary drug requests are 
resolved in a timely fashion. While PBM officials told us that they 
expect nonformulary drug request appeals to be adjudicated in a timely 
manner, they have not established a time frame in policy. Most VPEs 
also told us that they expect appeals to be adjudicated in a timely 
manner, and some stated that the 96-hour nonformulary drug request 
adjudication threshold also applies to appeals. However, we found that 
not all appeals processes may be structured to produce timely results. 
For example, officials from one medical center told us that the local 
P&T committee adjudicates appeals for nonformulary drugs that are not 
urgently needed. However, one official noted that appeals that go to 
the P&T committee can take a month or more to resolve as they are 
dependent on the P&T committee's meeting schedule. Other VPEs also 
stated that the medical centers in their regions may require P&T 
committees to adjudicate appeals. 

Furthermore, VA's PBM does not require VISNs and medical centers to 
collect and analyze data on the nonformulary drug request appeals 
process; therefore, the number of appeals, outcomes, and adjudication 
times are unknown systemwide. Of the 21 VISNs, only one VPE reported 
that the VISN collects and analyzes data on nonformulary drug request 
appeals.[Footnote 55] Some VPEs told us that medical centers may track 
nonformulary drug request appeals data. However, officials from three 
of the medical centers whom we interviewed told us that their sites do 
not collect such data, with an official from one noting that this is 
because the medical center has yet to receive any appeals. An official 
from the fourth medical center whom we interviewed said that appeals 
are published in P&T committee meeting notes, but that the medical 
center does not aggregate these data. 

VA Has Some Mechanisms to Obtain Beneficiary Input on the National 
Formulary and Make Its Drug Review Process Transparent and Is 
Considering Additional Steps: 

VA obtains beneficiary input on the national formulary mainly through 
VSO meetings and complaints, though some VISNs have taken additional 
steps to seek this input. Officials from VA's PBM told us that they 
make the drug review process transparent to veterans through online 
information about the national formulary, and some VPEs and medical 
center officials described undertaking other activities to educate 
beneficiaries. At the national level, VA officials are considering 
options for increasing beneficiary input on the national formulary and 
improving the transparency of the drug review process, and most VPEs 
and medical center officials told us there could be benefit to doing 
so. 

VA Obtains Beneficiary Input on the National Formulary Mainly through 
VSO Meetings and Complaints: 

VA officials told us that they may obtain beneficiary input on the 
national formulary through VSO meetings; although the extent to which 
pharmacy staff attend these meetings varies among VISNs and medical 
centers, and officials said that national formulary issues are not 
frequently discussed. All VPEs told us that medical centers in their 
regions hold local VSO meetings, and many said that there are VSO 
meetings held at the regional level as well. However, 3 of the 21 VPEs 
said that they or a VISN-level pharmacy representative regularly 
attend VSO meetings either at the regional or local level. Eleven VPEs 
said that they sometimes attend these meetings, and 7 said that they 
do not attend, but noted that pharmacy staff at medical centers may 
attend the meetings.[Footnote 56] Of the medical center chiefs of 
pharmacy we interviewed, one attends VSO meetings at the medical 
center regularly, two attend if invited, and one does not currently 
attend these meetings. 

While officials from most VISNs and medical centers whom we 
interviewed told us that pharmacy benefits are discussed during VSO 
meetings, many also said that issues related to the national formulary 
are not often raised. Rather, they stated that pharmacy benefit 
concerns tend to focus on operational issues, such as copayments and 
ordering medication refills. A few VPEs noted that when questions 
about the national formulary are raised during VSO meetings, they are 
usually patient-specific and addressed outside of the meetings. 

At the national level, the Chief Consultant from VA's PBM said that, 
as necessary, he discusses national formulary issues at VSO meetings 
held by VA's Under Secretary for Health on a quarterly basis; however, 
the Chief Consultant has only attended one of these meetings in the 
past 6 years. He said that he also receives occasional questions from 
VSO representatives about the national formulary. 

Outside of VSO meetings, most VPEs and medical center officials said 
that VA obtains beneficiary input on the national formulary through 
complaints by veterans or those acting on their behalf, such as 
providers, patient advocates, or members of Congress.[Footnote 57] 
Almost all VPEs noted that, at the regional level, they do not receive 
many complaints related to the national formulary and that most 
complaints are handled locally. Officials from three of the four 
medical centers we spoke with discussed receiving complaints on the 
national formulary. For example, an official from one medical center 
said that the medical center receives complaints from patients who 
transferred to VA from the private sector and want to stay on a 
medication that is not on VA's national formulary. 

Officials from VA's PBM told us that, at the national level, they 
occasionally receive complaints about the national formulary, but they 
do not routinely monitor beneficiary input in a centralized way. For 
example, while patient advocates are required to collect data on 
veteran complaints at medical centers, PBM officials reported that 
they do not have information on these or other local complaints. PBM 
officials also told us that while VA's Office of Quality and 
Performance administers the Survey of Healthcare Experiences of 
Patients, this survey is limited in scope and they do not use it to 
obtain beneficiary input on the national formulary. PBM officials 
reported that they are not aware of other surveys conducted for this 
purpose. 

Some VISNs have taken additional steps to seek beneficiary input on 
the national formulary. For example, one VPE whom we interviewed 
conducts site visits at medical centers in the region and talks to 
beneficiaries about national formulary issues during these visits. 
Another VPE said that the VISN recently added a 2-hour session at the 
end of its Executive Leadership Council meetings for beneficiaries to 
attend and discuss concerns. The VPE said that so far pharmacy benefit 
concerns have been raised at every meeting, including concerns about 
access to national formulary and nonformulary drugs. A VPE from a 
third VISN said that the region tried adding comment cards for 
pharmacy suggestions, but that they did not receive many suggestions. 

VA's PBM Provides National Formulary Information on Its Web Site, and 
Some VISNs and Medical Centers Engage in Other Activities to Educate 
Beneficiaries about the Drug Review Process: 

Officials from VA's PBM told us that they make the drug review process 
transparent to beneficiaries through national formulary information 
that is available online. Our review of PBM's Web site found that PBM 
posts the national formulary listing via an Excel spreadsheet, with a 
separate spreadsheet that highlights formulary changes. In addition, 
PBM provides a link to its Ez-Minutes newsletter, which is accessible 
online or through an e-mail subscription. Ez-Minutes provides a 
listing of national formulary decisions, but does not provide context 
for these decisions, such as when a drug is made nonformulary due to 
safety concerns.[Footnote 58] PBM also posts documents related to the 
drug review process on its Web site, such as drug monographs and 
criteria for use documents. Finally, the Web site provides answers to 
frequently asked questions about the national formulary. 

In addition to the information provided by VA's PBM, some VPEs and 
medical center officials described undertaking other activities to 
educate beneficiaries on VA's drug review process at the regional and 
local levels. For example, one VPE whom we interviewed said that the 
VISN had begun a new program called, "Formulary Awareness: Veterans 
Helping Veterans." The VPE told us that this program has a number of 
components including recruiting individuals to be in waiting rooms and 
wear buttons that say "Ask! Is your medication on formulary?" and 
providing brochures, pens, and tent cards at medical centers with 
information that includes a national formulary fact of the month. 
Another VPE said that the VISN sends a newsletter to veterans in its 
region that includes a section on how the national formulary works, 
points veterans to PBM's Web site, and provides pharmacist contact 
information if veterans have any questions. Likewise, one medical 
center official whom we interviewed posts explanations about why VA 
has a national formulary on the bulletin boards in pharmacy waiting 
room areas. Also, officials from three of the medical centers whom we 
interviewed noted that they send letters to beneficiaries when 
national formulary changes impact them, and officials from the fourth 
medical center said that they ask providers to inform veterans of 
these changes. 

VA Officials Are Considering Options for Increasing Beneficiary Input 
and Improving the Transparency of the Drug Review Process: 

At the national level, VA officials are considering options for 
increasing beneficiary input on the national formulary and improving 
the transparency of the drug review process. Options were discussed 
during a MAP meeting in January 2010, and while no formal decision was 
made, the overall consensus was to try to work within existing lines 
of communication. Following this meeting, officials from VA's PBM told 
us that MAP and the VPE Committee were in discussions to develop a 
process whereby veteran input at local VSO meetings could be reported 
and addressed nationally. The officials said that they would like to 
use local VSO meetings as a mechanism for obtaining input, because it 
would be easier for veterans to travel to meetings in their local area 
and these meetings may allow for input on not only national formulary 
issues, but also other pharmacy benefit issues that may be local in 
scope. In June 2010, options were again discussed during a meeting of 
MAP and the VPE Committee. PBM's chief consultant told us that a final 
decision was not made during this meeting, but that the next step is 
to discuss the issue with VHA management. 

Officials from most VISNs and medical centers we interviewed told us 
that there could be benefit to increasing beneficiary input on the 
national formulary or improving the transparency of VA's drug review 
process, and a number gave suggestions for doing so. For example, one 
medical center official said that the Ez-Minutes newsletter contains 
technical language and that it would be beneficial for VA's PBM to 
create something that was easier for beneficiaries and their 
representatives to understand. Likewise, a VPE suggested that national 
formulary changes be sent to local VSOs along with non-technical 
explanations of the reasons for the changes. Another VPE said that one 
way to better obtain beneficiary input on the national formulary would 
be to survey patients through an independent organization. 

While VA officials are considering options for increasing beneficiary 
input on the national formulary and improving the transparency of the 
drug review process, they have concerns about formally involving 
beneficiaries or their representatives in national formulary 
decisions. Specifically, this matter was raised during the January MAP 
meeting around a discussion about DOD's Uniform Formulary Beneficiary 
Advisory Panel.[Footnote 59] During our interviews, VPEs and medical 
center officials also raised concerns about this issue. Their concerns 
included that lay people may not have the technical knowledge to make 
evidence-based decisions, and that they could be unduly influenced by 
direct to consumer advertising from pharmaceutical companies. 
Officials were also concerned that another layer of review would slow 
down the drug review process. We spoke with DOD officials about the 
Uniform Formulary Beneficiary Advisory Panel, and they said that 
although the panel's input on DOD's formulary decisions is limited, it 
has provided useful feedback on how to operationalize formulary 
decisions, and resulted in DOD communicating formulary decisions in 
less technical terms to beneficiaries. 

Conclusions: 

In 2009, VA provided millions of prescriptions to veterans through its 
pharmacy benefit. While VA's process for reviewing drugs to decide 
whether they should be included on its national formulary is overseen 
by its PBM, VISNs and medical centers are responsible for implementing 
the nonformulary drug request process, and there is variation in the 
approaches that VISNs and medical centers take. For example, some 
VISNs and medical centers have more automated approaches to 
adjudicating nonformulary drug requests and collecting and reporting 
required data than others. In response to recommendations we made in 
our 2001 report, VA established a requirement for routine nonformulary 
drug requests to be adjudicated within 96 hours. However, some 
adjudications continue to surpass this threshold, and data reported to 
monitor timeliness are not always accurate or complete for all VISNs 
and their medical centers. Additionally, reported data are only 
required to include average adjudication times for nonformulary drug 
requests, which do not capture the total number of adjudications that 
fall outside VA's 96-hour standard. Finally, VA does not require that 
appeals of denied nonformulary drug requests are resolved within a 
certain time frame or that the outcomes of appeals are tracked. Given 
these limitations, additional steps are needed to ensure that veterans 
receive clinically necessary nonformulary drugs in a timely manner. 

VA is in the process of making changes to its pharmacy IT system 
through its PRE project, which could help facilitate more consistent 
implementation of the nonformulary drug request process among VISNs 
and medical centers. We previously reported on delays and challenges 
VA has faced implementing PRE, and it remains unclear when PRE will be 
complete. If PRE does not move forward, VA will continue to rely on 
its current IT system to manage its pharmacy benefit and depend on 
locally developed IT solutions to adjudicate nonformulary drug 
requests and collect data on outcomes. 

Recommendations for Executive Action: 

To provide assurance that requests for nonformulary drugs are 
adjudicated in a timely fashion, we recommend that the Secretary of 
Veterans Affairs take three actions. Specifically, the Secretary 
should direct the Under Secretary for Health to establish mechanisms 
to ensure that: 

* reported nonformulary drug request data are accurate and complete; 

* reported nonformulary drug request data are collected at the request-
level and analyzed by VA's PBM, VISNs, and medical centers at this 
level; and: 

* appeals of denied nonformulary drug requests are tracked. 

Additionally, we recommend that the Secretary of Veterans Affairs 
direct the Chief Information Officer to clarify plans regarding when 
functionality related to the nonformulary drug request process will be 
implemented under PRE. 

Agency Comments and Our Evaluation: 

In commenting on a draft of this report, VA stated that it generally 
agreed with our conclusions and concurred with our recommendations. 
VA's comments are reprinted in appendix I. Specifically, with regard 
to our first recommendation to establish mechanisms to ensure that 
requests for nonformulary drugs are adjudicated in a timely fashion, 
VA set a target date of October 30, 2010 for developing these 
mechanisms and plans to implement them during the first quarter of 
fiscal year 2011. With regard to our recommendation to clarify plans 
for when functionality related to the nonformulary drug request 
process will be implemented under PRE, VA acknowledged the importance 
of improving the nonformulary drug request process through PRE, but 
stated that addressing patient safety issues in VA's current pharmacy 
software takes precedence. VA reported that the department intends to 
complete field testing of currently approved PRE increments related to 
patient safety by November 1, 2010. VA further stated that it can then 
begin an analysis, which could be completed within 90 days, to 
determine how improvements to the nonformulary drug request process 
will be addressed in future PRE increments. We appreciate VA's focus 
on patient safety within PRE, but reiterate the importance of VA 
clarifying its plans for the remainder of the project. VA also 
provided technical comments, which we incorporated where appropriate. 

We are sending copies of this report to the Secretary of Veterans 
Affairs and appropriate congressional committees. In addition, the 
report is available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have questions about this report, please contact 
me at (202) 512-7114 or at dickenj@gao.gov. Contact points for our 
Office of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff members who made key 
contributions to this report are listed in appendix II. 

Signed by: 

John E. Dicken: 
Director, Health Care: 

List of Congressional Addressees: 

The Honorable Tim Johnson: 
Chairman: 
The Honorable Kay Bailey Hutchison: 
Ranking Member: 
Subcommittee on Military Construction, Veterans' Affairs, and Related 
Agencies: 
Committee on Appropriations: 
United States Senate: 

The Honorable Chet Edwards: 
Chairman: 
The Honorable Zach Wamp: 
Ranking Member: 
Subcommittee on Military Construction, Veterans' Affairs, and Related 
Agencies: 
Committee on Appropriations: 
House of Representatives: 

The Honorable Michael H. Michaud: 
Chairman: 
Subcommittee on Health: 
Committee on Veterans' Affairs: 
House of Representatives: 

[End of section] 

Appendix I: Comments from the Department of Veterans Affairs: 

Department of Veterans Affairs: 
Office of the Secretary: 

August 13, 2010: 

Mr. John E. Dicken: 
Director: 
Health Care: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Mr. Dicken: 

The Department of Veterans Affairs (VA) has reviewed the Government 
Accountability Office's (GAO) draft report, VA DRUG FORMULARY: Drug 
Review Process Is Standardized at the National Level, but Actions Are 
Needed to Ensure Timely Adjudication of Non-formulary Drug Requests 
(GA0-10-776) and generally agrees with GAO's conclusions and concurs 
with GAO's recommendations to the Department. 

The enclosure specifically addresses GAO's recommendations and 
provides technical comments to the draft report. VA appreciates the 
opportunity to comment on your draft report. 

Sincerely, 

John R. Gingrich: 
Chief of Staff: 

Enclosure: 

[End of letter] 

Enclosure: 

Department of Veterans Affairs (VA) Comments to Government 
Accountability Office (GAO) Draft Report: 

VA Drug Formulary: Drug Review Process Is Standardized at the National 
Level, but Actions Are Needed to Ensure Timely Adjudication of Non-
formulary Drug Requests (GA0-10-776): 

GAO Recommendation 1: To provide assurance that requests for 
nonformulary drugs are adjudicated in a timely fashion, we recommend 
that the Secretary of Veterans Affairs take three actions. 
Specifically, the Secretary should direct the Under Secretary for 
Health to establish mechanisms that: 

* Reported nonformulary drug request data are accurate and complete; 

* Reported nonformulary drug request data are collected at the request-
level and analyzed by VA's PBM, VISNs, and medical centers at this 
level; and; 

* Appeals of denied nonformulary drug requests are tracked. 

VA Comment: Concur. The Veterans Health Administration's Pharmacy 
Benefits Management Office will develop mechanisms to improve the 
collection, reporting and analysis of nonformulary request data and 
will assist staff from the Office of the Deputy Under Secretary for 
Health for Operations and Management to implement the new mechanisms. 
The target completion date to develop the mechanisms is October 30, 
2010, with implementation beginning in the first quarter of fiscal 
year 2011. 

GAO Recommendation 2: We recommend that the Secretary of Veterans 
Affairs direct the Chief Information Officer to clarify plans 
regarding when functionality related to the nonformulary drug request 
process will be implemented under PRE. 

VA Comment: Concur. Many of the requirements describing the non-
formulary request process are defined, but spread among the 
requirements documents describing the Ordering, Clinical Monitoring, 
Reporting and Drug file domains defined under the "original" Pharmacy 
Reengineering program. Not all parts of these domains have to be 
completed to implement the non-formulary request process, but parts of 
each would be required. Significant effort will be required to extract 
the requirements specific to these functions from those domains, and 
to identify any new ones necessary to implement the non-formulary 
request functions separate from the other features included in these 
domains. 

The PRE team and the Pharmacy Benefits Management resources supporting 
Pharmacy reengineering are fully engaged to support the current 
approved PRE increments for development under the Project Management 
Accountability System (PMAS). These increments provide functionality 
to address a number of patient safety issues existing in the legacy 
pharmacy applications, and are currently planned to complete field 
testing by November 1, 2010. While VA recognizes the importance of 
improving the non-formulary request process, current safety related 
pharmacy re-engineering projects take precedence, and improvements to 
the non-formulary request process will be handled in future PMAS 
increments. An analysis to determine the schedule and scope for this 
work can begin immediately after completion of field testing of 
current increments and could be completed within 90 days of initiation. 

[End of section] 

Appendix II: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

John E. Dicken, (202) 512-7114 or dickenj@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Jennifer Grover, Assistant 
Director; Mark Bird; Leonard Brown; Martha Kelly; Drew Long; Denise 
McCabe; Lisa Motley; Jessica Smith; Rachel Svoboda; Eric Trout; and 
Merry Woo made key contributions to this report. 

[End of section] 

Footnotes: 

[1] For purposes of this report, we use "providers" to refer to health 
care professionals with prescriptive authority within VA. 

[2] Drug classes are groups of drugs similar in chemical structure, 
pharmacological effect, or clinical use. 

[3] For purposes of this report, we use "medical centers" to refer to 
VA medical care facilities that provide drug prescriptions. 

[4] VistA, which began operation in 1983 as the Decentralized Hospital 
Computer Program, is the primary repository of clinical, 
administrative, and infrastructure data in VA. VistA is not 
standardized at the national level; rather, each medical center is 
responsible for maintaining its own VistA system. 

[5] VA established VISNs in 1995 to decentralize general decision- 
making and budgetary duties from its headquarters. Each VISN oversees 
heath care delivery for the VA medical centers in its designated area. 

[6] MAP is comprised of practicing VA physicians and clinicians from 
VA's PBM. The VPE Committee is comprised of pharmacists representing 
each VISN who generally serve both as the VISN representative on the 
VPE Committee and the manager of the VISN-Pharmacy Benefits Management 
Office. According to PBM officials, a MAP representative sits on the 
VPE Committee and a VPE Committee representative sits on MAP. 
Additionally, a clinical representative from the Department of Defense 
(DOD) sits on both committees. 

[7] H.R. Rep. No. 111-188, at 41 (2009). Although H.R. 3082 did not 
become law, the conference report for the Consolidated Appropriations 
Act for 2010, which included appropriations for VA, noted that the 
language of House Report 111-188 should be complied with unless 
specifically addressed to the contrary. See H.R. Conf. Rep. No. 111- 
366, at 1334 (2009). 

[8] VHA Handbook 1108.08, VHA Formulary Management Process, February 
2009. 

[9] FDA is the agency within the Department of Health and Human 
Services responsible for ensuring the safety and effectiveness of 
medical products. Before a drug can be marketed in the United States, 
it must be approved by the FDA. 

[10] For purposes of this report, a "new drug" is an FDA-approved new 
molecular entity, which is a drug that includes an active ingredient 
that has not previously been approved for marketing in the United 
States in any form. 

[11] The Chief Consultant heads VA's PBM and is responsible for 
planning and directing a variety of VA pharmacy issues including 
formulary management. 

[12] To achieve variation in the percentage of nonformulary drug 
prescriptions dispensed between 2006 and 2009, we selected medical 
centers that (1) consistently prescribed a higher level of 
nonformulary drugs compared to the average level, (2) consistently 
prescribed a lower level of nonformulary drugs compared to the average 
level, and (3) prescribed a higher level of nonformulary drugs in 2006 
and a markedly lower level in 2009. 

[13] GAO, Veterans Affairs: Health Information System Modernization 
Far from Complete; Improved Project Planning and Oversight Needed, 
[hyperlink, http://www.gao.gov/products/GAO-08-805] (Washington, D.C.: 
June 30, 2008). 

[14] We determined that data for the remaining eight VISNs and their 
medical centers were not reliable for our purposes, because VPEs for 
these VISNs told us that medical centers in their regions may include 
data on national formulary drugs in the nonformulary drug request data 
that they report to VA's PBM. 

[15] The National Defense Authorization Act for Fiscal Year 2000 
directed the Secretary of Defense to establish a pharmacy benefits 
program. See Pub. L. No. 106-65,  701, 113 Stat. 512, 677-80 (1999) 
(codified as amended at 10 U.S.C.  1074g). As part of this program, 
the law directed the Secretary of Defense to establish the P&T 
Committee to develop the uniform formulary, and the Uniform Formulary 
Beneficiary Advisory Panel to review and comment on the development of 
the uniform formulary. The panel was required to include members that 
represent the views and interests of beneficiaries. 

[16] Local drug files categorize drugs used within VA by a number of 
indicators, including whether a drug is on the national formulary or 
whether it is a nonformulary drug. The national drug file provides for 
standardization of the local drug files in all VA medical centers. 
VISNs 2 and 15 have combined local drug files at the regional level. 

[17] A VISN formulary committee is a group within each VISN comprised 
of clinical personnel such as physicians and pharmacists. 

[18] Although providers must receive authorization to prescribe 
nonformulary drugs, veterans pay the same copayment for national 
formulary and nonformulary drugs. There is no copayment for veterans 
receiving medications for treatment of service-connected conditions, 
veterans whose incomes fall below the maximum VA pension, and veterans 
who are exempt by other special authority. Other veterans are 
generally charged $8 for each 30-day prescription, though certain 
eligibility groups are charged $9. 

[19] According to VA's formulary management handbook, nonformulary 
drug requests are only to be approved when: (1) a documented 
contraindication exists to national formulary drug(s); (2) a 
documented adverse reaction occurred to national formulary drugs(s); 
(3) a documented therapeutic failure to national formulary 
alternatives exists; (4) no national formulary alternative exists; (5) 
the patient has previously responded to a nonformulary drug and 
serious risk is associated with a change to a national formulary drug; 
or (6) other circumstances having compelling evidence-based clinical 
reasons. 

[20] VA's formulary management handbook states that emergency requests 
for nonformulary drugs are to be addressed immediately. 

[21] VSOs are organizations that represent the interests of veterans. 
In addition to VSO representatives, veterans can be invited to attend 
VSO meetings. 

[22] GAO, VA Health Care: VA's Management of Drugs on Its National 
Formulary, [hyperlink, http://www.gao.gov/products/GAO/HEHS-00-34] 
(Washington, D.C.: Dec. 14, 1999); and GAO, VA Drug Formulary: Better 
Oversight Is Required, but Veterans Are Getting Needed Drugs, 
[hyperlink, http://www.gao.gov/products/GAO-01-183] (Washington, D.C.: 
Jan. 29, 2001). 

[23] VA does not review FDA-approved drugs that are not appropriate 
for use in the VA population, such as pediatric drugs. 

[24] As previously noted, for purposes of this report, a "new drug" is 
an FDA-approved new molecular entity, which is a drug that includes an 
active ingredient that has not previously been approved for marketing 
in the United States in any form. FDA also approves drugs for other 
reasons, such as when a prescription drug changes to over-the-counter 
status or a drug is approved for a new indication. 

[25] If VA determines that drugs within a class are therapeutically 
interchangeable, a decision may be made to have drug companies 
competitively bid for a committed-use contract. In these contracts, VA 
commits to using a drug throughout its health care system, thereby 
assuring the company a high volume of use. In turn, the drug company 
is more likely to offer a lower price. These contracts do allow for 
use of alternative drugs if it is determined that the committed-use 
contract drug is not clinically appropriate for a patient. 

[26] Other individuals or groups can submit drug review requests 
directly to VA's PBM, including the VHA Chief Medical Consultant, the 
VHA Chief Medical Officer, the VPE Committee, and MAP. 

[27] VISN formulary committees must submit a standardized drug review 
request form. Officials from VA's PBM said that they will deny drug 
review requests that are not routed through or reviewed by a VISN 
formulary committee, or if the request form is incomplete. 

[28] Clinicians from VA's PBM develop safety tables to examine 
reported adverse drug events within the patient population. The 
efficacy tables compare the effectiveness of the drug with others 
already on the national formulary and are based on the results of 
clinical trials. VA defines an adverse drug event as an injury 
resulting from the use of a drug, including adverse drug reactions and 
overdoses. 

[29] Officials from VA's PBM said that reviews of drugs for removal 
from the national formulary are generally completed in a shorter 
timeframe than reviews for drug additions and do not involve a formal 
process for soliciting comments from VISN and medical center staff. 
Officials said that drug class reviews also go through a process 
similar to drug additions, but MAP and the VPE Committee must review 
class reviews before they go to VA physicians and providers for 
comment. Additionally, PBM requires conflict of interest statements 
from staff submitting comments on drug class reviews, while for all 
other drug reviews, conflict of interest statements are voluntary. 

[30] Officials from VA's PBM told us that MAP and the VPE Committee 
hold quarterly in-person meetings, three of which are joint meetings 
of both groups. They said that the months when the committees do not 
meet in-person, they hold separate monthly teleconferences. In-between 
meetings, the committees communicate as needed. 

[31] Officials from VA's PBM told us that a representative from VA 
also sits on DOD's P&T Committee and votes on uniform formulary 
decisions; however, VA does not often collaborate with DOD when 
developing drug monographs or other documents related to the drug 
review process. 

[32] According to the Chief Consultant from VA's PBM, restrictions are 
generally used to limit prescribing privileges to specially trained 
providers or place a quantity limit on a drug. Criteria for use are 
clinical guidance that provide instructions on how to appropriately 
use a drug. 

[33] If a drug does not have established protocols for "off-label" 
use, VA's PBM recommends that providers consult with their P&T 
committee to determine appropriate use. 

[34] The Chief Consultant from VA's PBM told us that PBM monitors data 
transmitted from local drug files to ensure that drugs are 
appropriately marked as national formulary or nonformulary. If any are 
not appropriately marked, PBM asks medical centers to fix this. 

[35] Officials from VA's PBM stated that high priority is given to new 
drugs and drugs with emerging safety issues. VA's formulary management 
handbook states that the review of new drugs is prioritized based on 
their relevance to the veteran population and the availability of 
comprehensive, clinically relevant information, and that when these 
criteria are met reviews of new drugs ordinarily do not exceed one 
year. PBM officials also said that a drug may be given higher priority 
if there is an increase in demand, the drug has a potential efficacy 
benefit over existing drugs, or if there is a drug shortage for 
existing alternatives. 

[36] Officials from VA's PBM told us that abbreviated reviews are 
shorter than standard reviews and are not sent to VISN and medical 
center staff for comment. Abbreviated reviews are generally conducted 
for new formulations of existing drugs, drugs for which little 
available data exist, or drugs that will have little or no use in the 
veteran population. Of the 61 drugs VA considered for inclusion on the 
national formulary in 2008 and 2009, 24 of the reviews were 
abbreviated. 

[37] FDA's Web site lists 49 new drugs as being approved in 2008 and 
2009. Officials from VA's PBM told us that VA includes all new 
biologics in this category. In 2008 and 2009, some new biologics were 
not included on FDA's list, which is why VA's number of new drugs 
approved is slightly higher than FDA's number. 

[38] At the end of 2009, 95 percent of medical centers reported using 
CPRS to electronically process nonformulary drug requests. 

[39] According to interviews with VPEs and medical center staff, 
nonformulary drug requests are typically adjudicated by medical center 
pharmacists. However, one VISN has centralized adjudications of 
nonformulary drug requests and VISN-level pharmacists adjudicate most 
requests. 

[40] The VISN that centralized the appeals process is the same VISN 
that centralized adjudications of nonformulary drug requests. 

[41] In 2001, VHA undertook an initiative--called HealtheVet--to 
standardize its health information technology system and eliminate the 
approximately 128 different systems used by VISNs and medical centers. 
PRE is one of the HealtheVet components. 

[42] Among other things, PRE is expected to include new drug file and 
pharmacy data management systems, as well as new functions related to 
drug ordering, medication dispensing, and clinical monitoring. 

[43] Officials from VA's PBM told us that they are prioritizing PRE 
requirements based on patient safety. 

[44] According to some VPEs whom we interviewed, not all medical 
centers have the onsite IT expertise to customize CPRS to perform 
these types of functions. 

[45] VA officials told us that while OI&T has developed general 
requirements for capabilities related to collecting and reporting 
nonformulary drug request data, detailed specifications for these 
capabilities have not been clearly defined. 

[46] In 2008, we reported that VA had experienced significant delays 
and challenges with the development and implementation of HealtheVet, 
including PRE, and that VA had extended PRE's implementation date from 
2008 into 2011. We recommended that VA take several steps to better 
ensure the success of HealtheVet including that it develop a project 
management plan and a schedule for performing milestone reviews of 
HealtheVet projects. 
[hyperlink, http://www.gao.gov/products/GAO-08-805]. 

[47] In June 2009, VA implemented the Program Management 
Accountability System in an effort to increase efficiency and 
accountability for IT projects, and allow the department to take 
corrective actions sooner. 

[48] Enhanced drug order checks are one of the capabilities the first 
six PRE increments are intended to support. Of the over 40,000 adverse 
drug events reported during fiscal year 2008, VA estimated that 526 
events were related to dosage order checks and projected that enhanced 
drug order checks could have prevented many of these. As a result, VA 
has prioritized their development in PRE to better ensure patient 
safety. 

[49] OI&T officials told us that a number of factors have delayed 
implementation of these increments, but that contracting difficulties 
were the primary factor. Officials from VA's PBM noted that the way VA 
awards contracts for PRE has caused problems. They explained that 
contracts for IT staff are awarded for a specified time period rather 
than the completion of a deliverable. For example, contractors have 
been changed during the middle of major testing activities and halted 
progress. OI&T officials said that new contracting guidance under the 
Program Management Accountability System should help address this 
issue. 

[50] When outliers are present, it can be useful to calculate the 
median which is the midpoint of the data that separates the lower half 
of the distribution from the upper half. 

[51] Medical centers that use CPRS to process nonformulary drug 
requests electronically may also use it to process requests for 
restricted national formulary drugs; however, not all medical centers 
have customized CPRS so that it distinguishes the two types of 
requests. As a result, CPRS-generated nonformulary drug request 
reports may also include data on requests for restricted formulary 
drugs. 

[52] VPEs and medical center officials provided examples of why 
nonformulary drug request adjudications could exceed 96 hours, 
including medical center workload and staffing constraints, complex 
patient cases, and the need for information from private providers 
outside of VA. 

[53] In addition to the 7 VISNs, several other VISNs each had at least 
one medical center with a reported nonformulary drug request average 
adjudication time over 96 hours in 2009. However, VPEs from these 
VISNs told us that requests for restricted national formulary drugs 
may be included in reported nonformulary drug request data, and as a 
result, we did not include them in our total count. 

[54] Overall, quarterly nonformulary drug request average adjudication 
times for medical centers across the 13 VISNs ranged from 1 hour to 
240 hours. 

[55] This VPE was from the one VISN that has centralized adjudications 
of nonformulary drug requests and appeals and told us that the VISN 
reviews the percentage of appeals upheld and overturned by drug, 
adjudicating VISN pharmacist, and medical center provider. 

[56] A majority of the VPEs who said they sometimes attend VSO 
meetings indicated that they do so to discuss pharmacy-related topics. 

[57] Patient advocates are VA employees who are responsible for 
receiving and acting on complaints from veterans at medical centers. A 
report issued by the Institute of Medicine in 2000 found that national 
formulary concerns constituted less than 1 percent of all complaints 
reported to patient advocates, see Institute of Medicine, Description 
and Analysis of the VA National Formulary (Washington, D.C.: 2000). 

[58] Another approach, currently employed by DOD, is to make national 
P&T committee meeting minutes available online. DOD's minutes include 
a more comprehensive discussion of national formulary decisions than 
VA's Ez-Minutes. In addition to listing decisions, DOD's minutes 
include the clinical evidence used to make decisions, justification 
for recommendations, and a breakdown of voting results. The minutes do 
not include proprietary drug cost information. 

[59] The Uniform Formulary Beneficiary Advisory Panel reviews and 
comments on the recommendations of DOD's P&T Committee in order to 
provide a beneficiary perspective on formulary decisions. Final 
formulary decisions are based on both the P&T Committee's 
recommendations and the Uniform Formulary Beneficiary Advisory Panel's 
comments. 

[End of section] 

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